Catalog Number

5720912

Brand Name

Henry Schein

Version/Model Number

5720912

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JDZ

Product Code Name

MIXER, CEMENT, FOR CLINICAL USE

Public Device Record Key

59e773d4-1693-4d5a-b3b1-5a520a39e8e0

Public Version Date

September 05, 2019

Public Version Number

1

DI Record Publish Date

August 28, 2019

Package DI Number

20304040095694

Quantity per Package

25

Contains DI Package

10304040095697

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case